US8855779B2 - Methods of diagnosis and treatment of wounds, methods of screening for electrical markers for wounds prognosis in patients - Google Patents
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Definitions
- the present invention relates to a method for diagnosing the prognosis of damaged animal tissues, including human tissue by detection of an electric current flow through the tissue.
- the invention relates to a method and procedure for measuring, recording and analyzing the electrical field in and around areas of a living body and in particular the method identifies and defines a discrete electrical profile of a wound during a healing, worsening or stopped condition.
- Electrophysiology is the science and branch of physiology that delves into the flow of ions in biological tissues, the electrical recording techniques which enable the measurement of this flow and their related potential changes.
- One system for such a flow of ions is the Power Lab System by ADInstruments headquartered in Sydney, Australia.
- Clinical applications of extracellular recording include among others, the electroencephalogram and the electrocardiogram. To understand these biomedical signals, it is necessary to understand signal types, properties and statistics.
- Deterministic signals are exactly predictable for the time span of interest. Deterministic signals can be described by mathematical models. Stochastic or random signals are those signals whose value has some element of chance associated with it, therefore it cannot be predicted exactly. Consequently, statistical properties and probabilities must be used to describe stochastic signals. In practice, biological signals often have both deterministic and stochastic components.
- a number of statistics may be used as a measure of the location or “centre” of a random signal. These include,
- signals are continuous time signals when the independent variable is continuous, therefore the signals are defined for a continuum of values of the independent variable X(t).
- An analogue signal is a continuous time signal.
- Discrete time signals are only defined at discrete times; the independent variable takes on only a discrete set of values X(n).
- a digital signal is a discrete time signal.
- a discrete time signal may represent a phenomenon for which the independent variable is inherently discrete (e.g., amount of calories per day on a diet).
- a discrete signal may represent successive samples of an underlying phenomenon for which the independent variable is continuous (e.g., a visual image captured by a digital camera is made of individual pixels that can assume different colors).
- any waveform can be mathematically decomposed in a sum of different waveforms. This is what the so-called Fourier analysis does; it decomposes the waveform in different components and measures the amplitude (power) of each frequency component. What is plotted is a graph of power (amplitude) vs. frequency.
- the present invention is a diagnostic method that identifies and defines a discrete electrical profile of a wound during a healing, worsening or stopped condition so as to provide a prognosis for such wounds.
- a method of detecting the current state of living human and animal target tissue comprising: (a) detecting and recording an electrical signal in and around an area of the target tissue, the electrical signal being a stochastic signal; (b) transforming the stochastic signal into a voltage versus frequency spectra using a Fast Furier Transform (FFT) algorithm; (c) comparing a graph of a resultant FFT level of the target tissue to at least one graph of a baseline FET level; and (d) determining a current state of the target tissue based on the comparison.
- FFT Fast Furier Transform
- the detecting and recording is implemented as detecting and recording an alternating current (AC) signal and displaying the alternating current (AC) signal as voltage over time.
- AC alternating current
- the FFT level is implemented as an electrical frequency spectra from 0 to 5000 Hz.
- the FFT level is implemented as an electrical frequency spectra from 0 and 3000 Hz.
- the target tissue is an area of injury in a patient.
- the baseline is implemented as the FFT levels for healthy non-injured subjects.
- the baseline is implemented as an FFT level for normal healthy tissue and an increase in the FFT level of the target tissue relative to the baseline FFT level is indicative of wound conditions.
- the current state of the target tissue includes one from a list that includes worsening condition, healing condition and stopped condition.
- the FFT level of the target tissue is implemented so as to enable differentiation of wounds that are in a worsening condition due to infection from wounds that are in a healing state and from wounds that are in a stopped state.
- the FFT level reference markers are implemented so as to indicate wounds in a worsening state, a healing state and a stopped state
- the FFT level reference markers are implemented as mean FFT level profiles detected in healthy subjects, patients with chronic wounds diagnosed as worsening, patients with chronic wounds diagnosed as healing and patients with chronic wounds diagnosed as stopped.
- the determining further includes determining a prognosis for the target tissue.
- a method for determining a prognosis for wounds in a living human and animal target tissue comprising: (a) detecting and recording a first electrical signal in and around an area of the target tissue a second electrical signal in and around contralateral tissue, the first and the second electrical signals being a stochastic signals; (b) transforming the first and the second electrical signals into a voltage versus frequency spectra using a Fast Fourier Transform (FFT) algorithm; (c) comparing a graph of a resultant FFT level of the first electrical signal to at least one graph of a baseline FFT level and an FFT level of the second electrical signal; and (d) determining a prognosis of the target tissue based on the comparison.
- FFT Fast Fourier Transform
- a method of a prognosis for wounds in living human and animal target tissue comprising: (a) detecting and recording an electrical signal in and around an area of the target tissue, the electrical signal being a stochastic signal; (b) transforming the stochastic signal into a voltage versus frequency spectra using a Fast Fourier Transform (FFT) algorithm; (c) comparing a graph of a resultant FFT level of the target tissue to at least one FFT level referenced marker; and (d) determining a current state of the target tissue based on the comparison.
- FFT Fast Fourier Transform
- the FFT level reference markers are implemented so as to indicate wounds in a worsening state, a healing state and a stopped state
- the FFT level reference markers are implemented as mean FFT level profiles detected in healthy subjects, patients with chronic wounds diagnosed as worsening, patients with chronic wounds diagnosed as healing and patients with chronic wounds diagnosed as stopped.
- an electrical stimulator system for providing treatment to a target tissue
- the electrical stimulator system comprising: (a) a first component configured for detecting and recording an electrical signal in and around an area of the target tissue, the electrical signal being a stochastic signal, the device further configured to transform the stochastic signal into a voltage versus frequency spectra using a Fast Fourier Transform (FFT) algorithm, use a resultant FFT level to generate data regarding a current state of the target tissue and transmit the data; (b) a second component configured to deliver an electrical current to the target tissue, the devise configured to receive the data from the first component, characteristics of the electrical current being determined by the data.
- FFT Fast Fourier Transform
- the characteristics include a specific frequency spectra.
- the electrical current delivered to the target tissue is an alternate current signal.
- a method of determining the presence of infection in a worsening wound in living human and animal tissue comprising: (a) detecting and recording a first electrical signal in and around an area of the target tissue a second electrical signal in and around contralateral tissue, the first and the second electrical signals being a stochastic signals; (b) transforming the first and the second electrical signals into a voltage versus frequency spectra using a Fast Fourier Transform (FFT) algorithm, (c) comparing a graph of a resultant FFT level of the first electrical signal to an FFT level of the second electrical signal and at least one graph of a baseline FFT level of wounds in a worsening state without infection; and (d) determining a presences of infection in the target tissue based on the comparison.
- FFT Fast Fourier Transform
- FIG. 1 illustrates placement of electrodes near a wound
- FIG. 2 illustrates the placement of electrodes near a wound and on the contralateral healthy limb
- FIG. 3A is a graph of raw baseline data for a healthy subject
- FIG. 3B is a graph of baseline data of FIG. 3A after transformation to FFT levels
- FIG. 3C is a graph of baseline data of FIG. 3B when filtered
- FIG. 4 is a graph of the FFT baseline for healthy subjects
- FIG. 5 is a graph of the FFT baseline for healthy subjects, the FFT level for chronic wounds and the FFT level for the contralateral non-injured tissue of the subjects with wounds;
- FIG. 6 is a graph of the FFT baseline for healthy subjects and the FFT level for wounds in a stopped state
- FIG. 7 is a graph of the FFT baseline for healthy subjects and the FFT level for wounds in a worsening state
- FIG. 8 is a graph of the FFT baseline for healthy subjects and the FFT level for wounds in a healing state
- FIG. 9 is a graph of the FFT baseline for healthy subjects, the FFT level for wounds in a stopped state, the FFT level for wounds in a worsening state and the FFT level for wounds in a healing state;
- FIG. 10 is a chart that summarizes the statistical analysis/comparisons between the groups
- FIG. 11 is a graph the FFT level around a chronic wound and the FFT level for the contralateral non-injured tissue for the group of subjects having wounds in a worsening state without injection;
- FIG. 12A-12E are graphs the FFT level around a chronic wound and the FFT level for the contralateral non-injured tissue for five individual subjects having wounds in a worsening state due to infection;
- FIG. 13 is a flowchart of a method, according to the teachings of the present invention, of determining if a worsening wound in target tissue is infected;
- FIG. 14 is a flowchart of a method, according to the teachings of the present invention, for detecting the current state of living human and animal target tissue;
- FIG. 15 is a flowchart of a first method, according to the teachings of the present invention, for determining a prognosis for wounds in living human and animal target tissue;
- FIG. 16 is a flowchart of a second method, according to the teachings of the present invention, for determining a prognosis for wounds in living human and animal target tissue.
- the present invention relates to a diagnostic method that identifies and defines a discrete electrical profile of a wound during a healing, worsening or stopped condition so as to provide a prognosis for such wounds.
- Chronic wounds are trapped in a non-advancing phase of healing and are unable to progress through the sequential stages of tissue repair.
- studies have shown that human chronic wounds differ in their biochemical, molecular and mechanistic characteristics such as reduced levels of metalloproteinase inhibitors and diminished growth factor activity. Therefore, unlike acute wounds that are dynamically changed in time, chronic wounds may be considered relatively stable and thus could provide an example of the profile of their mean electric fields.
- the mean electrical measurements around chronic wounds exhibited significantly higher amplitude (voltage) above the baseline measurements in healthy subjects.
- the debridement procedure provided an excellent example for evaluating the dynamics of electrical frequency pattern before and during this procedure. It should be emphasized that in these cases it was possible to simultaneously analyze the dynamics of the signals before and during acute injury on both the wound and contralateral non-injured organs. The generated signal exhibited significantly higher amplitude above the amplitude levels of the basal signal and its frequency spectra exceeded 1000 Hz much above the chronic wound signals. Furthermore, the present inventors found the interesting result of the simultaneous increase and existence of these injury signals on both the wound and on the contralateral healthy limb of the same patients.
- the method of detecting the prognosis of wounds in a patient of the present invention includes detecting and record an electrical signal, specifically alternating current displayed as voltage during time, from the patient, wherein the electrical signal is a stochastic signal.
- the stochastic signal is then transformed to voltage versus frequency spectra by the Fast Fourier Transform (FFT) algorithm.
- the FFT graph comprises an electrical frequency spectra from 0 to 5000 Hz and more specific to 0 and 1000 Hz.
- the FFT level of the wound sample is then compared to the (baseline) FFT level in a normal sample, such as a healthy subject for example. An increase in the level of the FFT relative to the normal sample is indicative of wound conditions.
- the prognostic method of the present invention can also be a prognostic scale, or a prognostic electrical scale, with a discrete FFT such that the FFT is specific to chronic wounds that enables to differentiate between wounds that are in a worsening state, wounds that are in healing state and wounds that are neither worsening nor healing but are in a stopped state.
- the stochastic signal is detected by using alternating current measurements with the signal displayed as voltage during time.
- the stochastic signal transformed to FFT may be displayed as voltage as a function of frequencies, such that the FFT level is defined as the area under the voltage versus frequency curve.
- An alternating current probe may be used to detect the stochastic signal that is then transformed by algorithm to FFT.
- the probe may include, but is not limited to, electrodes, anodes, and cathodes, placed around the wound.
- a ground reference electrode may be placed on the skin contralateral healthy limb.
- the prognostic scale of the present invention may use the mean FFT of healthy subjects as the baseline value to define a wound as worsening, healing or stopped.
- the prognostic scale of the present invention may use reference markers taken from healthy tissue, worsening wounds, healing wounds and stopped wounds to define a wound as worsening, healing or stopped.
- the reference markers may be, by non-limiting example, the mean FFT profiles detected in healthy subjects, patients with chronic wounds diagnosed as worsening, patients with chronic wounds diagnosed as healing and patients with chronic wounds diagnosed as stopped.
- the prognosis scale of the present invention may be operationally linked to a device for delivering alternating current to human tissue such that upon determination of the current status of the wound, the device transmits to the tissue an alternating current with specific frequency spectra for worsening, healing or stopped wounds.
- FIGS. 1 and 2 illustrate the electrical recordings procedure of the present invention which affixes two electrodes 2 and 4 on both proximal and distal sides across the medial axis of the injured skin 6 and signals were measured against the third ground electrode (not shown).
- two AC recording devices can be used, as seen in FIG. 2 , with one device 8 placed around the wound and the other device 10 together with electrodes 2 ′ and 4 ′. on the contralateral healthy limb 12 for real time comparison.
- device 8 may electrical stimulator system for providing treatment to a target tissue that includes a first component configured for detecting and recording an electrical signal in and around an area of the target tissue 6 , transform the signal into a voltage versus frequency spectra using a Fast Fourier Transform (FFT) algorithm, use a resultant FFT level to generate data regarding a current state of the target tissue and transmit the data to a second component configured to deliver an electrical current to the target tissue 6 , such that the characteristics of the electrical current delivered is determined by the data regarding a current state of the target tissue.
- FFT Fast Fourier Transform
- FIG. 3A illustrates the AC signal displayed during time (voltage against time) as a stochastic cue.
- FFT Fast Fourier Transform
- This transformation enables display of the original detected signal as voltage versus frequency spectra as illustrated in FIG. 3B .
- This signal processing approach enables the profiling of discrete signals with significant differences in amplitude (voltage) and/or frequency within a filter set at 0.5 to 1000 Hz and up to 2000 Hz.
- the sampling rate is reduced to one sample per second (1 Hz) by the this an improved signal obtained with less noises as seen in FIG. 3C .
- FIG. 4 shows the mean frequency spectra detected on the healthy skin of healthy subjects that served as the baseline for the prognosis of wounds.
- FIG. 5 is a graph of the FFT baseline for healthy subjects 40 , the FFT level for chronic wounds 50 and the FFT level for the contralateral non-injured tissue of the subjects with wounds 52 .
- the mean electrical measurements around chronic wounds 50 exhibited significantly higher amplitude (voltage) above the baseline measurements of healthy subjects 40 .
- These stochastic signals were characterized by mean electrical frequency spectra within the range of 0.5 to 1000 Hz.
- the mean maximum voltage (Vmax) of this signal was found in the range of 0.5 to 50 Hz (the frequency spike around 50 Hz is considered as environmental electrical radiation).
- the signal reduced exponentially to its minimal voltage (Vmin) of about 10 nV which was detected around 200 and up to 1000 Hz (in the baseline curve) and of about 20 nV within the range of 700 to 1000 Hz in the chronic wounds group.
- Vmin minimal voltage
- AUC Area Under the Curve
- FIG. 6 shows the significant higher amplitudes exhibited by the mean FFT levels of the group of patients having wounds in stopped condition 60 above the mean FFT levels of healthy subjects 40 .
- FIG. 7 shows the significant higher amplitudes exhibited by the mean FFT levels of the group of patients having wounds in worsening condition 70 above the mean FFT levels of healthy subjects 40 .
- FIG. 8 shows the significant higher amplitudes exhibited by the mean FFT levels of the group of patients having wounds in healing condition 80 above the mean FFT levels of healthy subjects 40 .
- FIG. 9 shows the comparison between the graphs of FIGS. 6-8 . Specifically, the FFT levels for healthy subject compared to the FFT levels of patients with chronic wounds heaving in a stopped state 60 , worsening state 70 or healing state 80 . The figure shows that significant differences are found between the three prognostic levels of wounds. The worsening and healing are above stopped and all three are higher that the baseline of healthy subjects 40 .
- FIG. 10 summarizes the statistical analysis/comparisons between the groups.
- the F value 100 which is ⁇ 0.0001, shows the significance of the differences between wounds in the stopped state 104 , worsening state 108 and healing state 112 in comparison to the baseline healthy subjects 114 .
- the chart also shows that the mean values of contralateral healthy limb 102 , 106 and 110 for each group respectively can be used as a marker for wound prognosis. It should be noted that while the mean values of worsening 108 and healing 112 wounds are close to each other, their relationship to the mean values of their respective contralateral healthy limbs 106 and 110 are noticeably different.
- FIG. 11 is a graph the FFT level around a chronic wound 110 and the FFT level for the contralateral no injured tissue 110 ′ for a group of subjects having wounds in a worsening state without injection.
- FIGS. 12A-12E are graphs the FFT level around a chronic wound 120 and the FFT level for the contralateral non-injured tissue 120 ′ for five individual subjects having wounds in a worsening state due to infection. It will be readily appreciated that in the group having wounds in a worsening state without injection ( FIG.
- the FFT level around the chronic wound 110 and the FFT level for the contralateral non-injured tissue 110 ′ are substantially the same and the line for the FFT level around the chronic wound 110 is obscured by the line FFT level for the contralateral non-injured tissue 110 ′.
- the FFT level around the chronic wound 120 and the FFT level for the contralateral non-injured tissue 120 ′ for the five individual subjects having wounds in a worsening state due to infection ( FIGS. 12A-12E ) are both statistically and visually quite different. Therefore, according to the teaching of the present invention, it is possible to distinguish wounds in a worsening state due to infection from wounds in a worsening state without injection.
- the present invention includes, as illustrated in the flowchart of FIG. 13 a method of determining if a worsening wound in living human and animal tissue is infected.
- the method including the steps of:
- FIG. 14 illustrates a method of the present invention for detecting the current state of living human and animal target tissue. The method includes the steps of:
- FIG. 15 illustrates a first method of the present invention for determining a prognosis for wounds in living human and animal target tissue. The method includes the steps of:
- FIG. 16 illustrates a second method of the present invention for determining a prognosis for wounds in living human and animal target tissue. The method includes the steps of:
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Priority Applications (15)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/477,944 US8855779B2 (en) | 2008-11-27 | 2009-06-04 | Methods of diagnosis and treatment of wounds, methods of screening for electrical markers for wounds prognosis in patients |
CA2744687A CA2744687A1 (en) | 2008-11-27 | 2009-10-25 | Methods of diagnosis and treating wounds and screening for electrical markers for wounds prognosis |
JP2011538077A JP2012509732A (ja) | 2008-11-27 | 2009-10-25 | 創傷の診察と治療の方法と創傷の予後の電気マーカをスクリーニングする方法 |
KR1020117014631A KR20110099117A (ko) | 2008-11-27 | 2009-10-25 | 상처의 진단 및 치료, 및 상처의 예후를 위한 전자 마커들의 표시 방법들 |
SG2011038593A SG171842A1 (en) | 2008-11-27 | 2009-10-25 | Methods of diagnosis and treating wounds and screening for electrical markers for wounds prognosis |
AU2009321282A AU2009321282A1 (en) | 2008-11-27 | 2009-10-25 | Methods of diagnosis and treating wounds and screening for electrical markers for wounds prognosis |
PCT/IB2009/054708 WO2010061297A1 (en) | 2008-11-27 | 2009-10-25 | Methods of diagnosis and treating wounds and screening for electrical markers for wounds prognosis |
MX2011005651A MX2011005651A (es) | 2008-11-27 | 2009-10-25 | Metodos para el diagnostico y tratamiento de heridas y analisis con marcadores electricos para el pronostico de las heridas. |
EP09828713A EP2355694A1 (en) | 2008-11-27 | 2009-10-25 | Methods of diagnosis and treating wounds and screening for electrical markers for wounds prognosis |
EA201100833A EA201100833A1 (ru) | 2008-11-27 | 2009-10-25 | Способы диагностики ран, лечения ран и выявления электрических маркеров для прогнозирования состояния ран |
CN2009801480978A CN102227188A (zh) | 2008-11-27 | 2009-10-25 | 诊断和治疗损伤的方法与用于病人损伤的预后的电标记的筛选方法 |
IL213140A IL213140A0 (en) | 2008-11-27 | 2011-05-25 | Methods of diagnosis and treating wounds and screening for electrical markers for wounds prognosis |
ZA2011/04368A ZA201104368B (en) | 2008-11-27 | 2011-06-13 | Methods of diagnosis and treating wounds and screening for electrical markers for wounds prognosis |
US14/472,445 US9468758B2 (en) | 2008-11-27 | 2014-08-29 | Wound diagnosis |
US14/809,404 US20150328450A1 (en) | 2008-11-27 | 2015-07-27 | Wound treatment |
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US12/477,944 US8855779B2 (en) | 2008-11-27 | 2009-06-04 | Methods of diagnosis and treatment of wounds, methods of screening for electrical markers for wounds prognosis in patients |
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US (1) | US8855779B2 (ja) |
EP (1) | EP2355694A1 (ja) |
JP (1) | JP2012509732A (ja) |
KR (1) | KR20110099117A (ja) |
CN (1) | CN102227188A (ja) |
AU (1) | AU2009321282A1 (ja) |
CA (1) | CA2744687A1 (ja) |
EA (1) | EA201100833A1 (ja) |
IL (1) | IL213140A0 (ja) |
MX (1) | MX2011005651A (ja) |
SG (1) | SG171842A1 (ja) |
WO (1) | WO2010061297A1 (ja) |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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US9468758B2 (en) | 2008-11-27 | 2016-10-18 | E-Qure Corp. | Wound diagnosis |
Families Citing this family (2)
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EP2990075B1 (en) * | 2014-08-29 | 2018-05-16 | ADB International Group Inc. | Wound diagnosis |
KR102569089B1 (ko) * | 2020-07-08 | 2023-08-22 | 대구가톨릭대학교산학협력단 | 압박 궤양의 예후 판단 방법 및 이를 위한 생물학적 시료를 준비하는 방법 |
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2009
- 2009-06-04 US US12/477,944 patent/US8855779B2/en not_active Expired - Fee Related
- 2009-10-25 EP EP09828713A patent/EP2355694A1/en not_active Withdrawn
- 2009-10-25 AU AU2009321282A patent/AU2009321282A1/en not_active Abandoned
- 2009-10-25 CA CA2744687A patent/CA2744687A1/en not_active Abandoned
- 2009-10-25 KR KR1020117014631A patent/KR20110099117A/ko not_active Application Discontinuation
- 2009-10-25 SG SG2011038593A patent/SG171842A1/en unknown
- 2009-10-25 JP JP2011538077A patent/JP2012509732A/ja active Pending
- 2009-10-25 WO PCT/IB2009/054708 patent/WO2010061297A1/en active Application Filing
- 2009-10-25 EA EA201100833A patent/EA201100833A1/ru unknown
- 2009-10-25 MX MX2011005651A patent/MX2011005651A/es not_active Application Discontinuation
- 2009-10-25 CN CN2009801480978A patent/CN102227188A/zh active Pending
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Also Published As
Publication number | Publication date |
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EP2355694A1 (en) | 2011-08-17 |
MX2011005651A (es) | 2011-09-22 |
EA201100833A1 (ru) | 2012-01-30 |
ZA201104368B (en) | 2022-08-31 |
IL213140A0 (en) | 2011-07-31 |
US20100131031A1 (en) | 2010-05-27 |
SG171842A1 (en) | 2011-07-28 |
CA2744687A1 (en) | 2010-06-03 |
JP2012509732A (ja) | 2012-04-26 |
KR20110099117A (ko) | 2011-09-06 |
WO2010061297A1 (en) | 2010-06-03 |
AU2009321282A1 (en) | 2011-06-30 |
CN102227188A (zh) | 2011-10-26 |
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